What is the use of Ozempic (semaglutide)?

From the Guidelines

Ozempic (semaglutide) is primarily used for the treatment of type 2 diabetes and obesity, with a recommended dose of 2.4 mg injected subcutaneously once weekly, as it has been shown to significantly reduce weight and improve weight-related comorbidities, as well as decrease the risk of cardiovascular events 1.

Key Points

• Ozempic works by mimicking the hormone GLP-1, which helps regulate blood sugar and reduce appetite, leading to significant weight loss, with a mean weight loss of 14.9% and 16.0% in the STEP 1 and STEP 3 trials, respectively 1.
• The medication has been FDA-approved for the treatment of obesity in 2021 and has been shown to be effective in reducing weight and improving weight-related comorbidities, with a lower rate of gastrointestinal adverse events compared to other GLP-1 receptor agonists 1.
• The American Gastroenterological Association recommends using semaglutide 2.4 mg with lifestyle modifications for the long-term treatment of obesity, due to its glucoregulatory benefits and association with a lower risk of pancreatitis and gallbladder disease 1.

Administration and Monitoring

• The typical starting dose of Ozempic is 0.25 mg injected subcutaneously once weekly for the first four weeks, then increased to 0.5 mg weekly, with possible further increases to 1 mg or 2 mg weekly based on clinical response.
• Patients should store Ozempic in the refrigerator before first use and at room temperature (up to 30 days) after opening, and inject the medication in the abdomen, thigh, or upper arm, rotating injection sites.
• Regular medical follow-ups are necessary to monitor the effectiveness and potential side effects of Ozempic, including nausea, vomiting, diarrhea, abdominal pain, and constipation, which often improve over time.

Clinical Considerations

• Ozempic may be prioritized over other approved anti-obesity medications for the long-term treatment of obesity due to its magnitude of net benefit and glucoregulatory benefits 1.
• Gradual dose titration may help mitigate adverse effects, and patients should be counseled on the potential risks and benefits of Ozempic, including the increased risk of pancreatitis and gallbladder disease.

From the FDA Drug Label

OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as: • an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus • to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease

The use of Ozempic (semaglutide) is:

• Improving glycemic control: as an adjunct to diet and exercise in adults with type 2 diabetes mellitus.
• Reducing cardiovascular risk: to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease 2.

From the Research

Use of Ozempic (Semaglutide)

• Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for the treatment of type 2 diabetes (T2D) 3, 4, 5.
• It is available in both subcutaneous and oral formulations, with the subcutaneous formulation being administered once weekly 3, 5 and the oral formulation being taken on an empty stomach upon waking with a sip of plain water and at least 30 minutes before the first food, beverage, or other oral medications of the day 4.
• Semaglutide has been shown to lower blood glucose by stimulating the release of insulin and also lower body weight 3, 5, 6, 7.
• The efficacy and safety of semaglutide have been demonstrated in several clinical trials, including the SUSTAIN programme, which showed that semaglutide was effective in reducing HbA1c and body weight in patients with T2D 3, 7.
• A systematic review and network meta-analysis found that oral semaglutide was non-inferior to subcutaneous semaglutide and superior to placebo and other GLP-1 receptor agonists in reducing HbA1c and body weight 6.
• A phase 3B trial (SUSTAIN FORTE) found that once-weekly semaglutide 2.0 mg was superior to 1.0 mg in reducing HbA1c, with additional body weight loss and a similar safety profile 7.

Administration and Dosage

• Subcutaneous semaglutide is administered once weekly using a prefilled pen for subcutaneous injection 3, 5.
• Oral semaglutide should be taken on an empty stomach upon waking with a sip (≤120 mL) of plain water and at least 30 minutes before the first food, beverage, or other oral medications of the day 4.
• The recommended dose of semaglutide varies depending on the formulation and individual patient needs, with doses ranging from 0.5 to 2.0 mg once weekly for subcutaneous administration 3, 7 and 14.0 mg for oral administration 6.

Safety and Efficacy

• The most common adverse events associated with semaglutide are gastrointestinal disorders, such as nausea, diarrhea, and vomiting 4, 6, 7.
• Semaglutide has been shown to be effective in reducing HbA1c and body weight in patients with T2D, with a similar safety profile to other GLP-1 receptor agonists 3, 6, 7.
• A higher dose of semaglutide (2.0 mg) has been found to provide additional glycaemic control and body weight loss compared to a lower dose (1.0 mg) 7.